FDA.report

510(k) K905392

Device
HT4-SERIES HYSTEROSCOPES AND ACCESSORIES
Applicant
FRIGITRONICS, INC.
510(k) number
K905392
Product code
HIH  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-30
Date received
1990-11-30
Regulation
884.1690
Classification name
Hysteroscope (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CHARLES L ROSE
Address
1963 Rock St. Suite #17 Mountain View CA US 94043 94043

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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